Status and phase
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Treatments
About
To further understand the tolerability of glucagon.
Full description
To determine the tolerability of glucagon infusion administered in an escalating step-wise manner in healthy obese subjects
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Treatment with any medication known to significantly impact body weight (e.g., weight loss medications, atypical antipsychotics) within 3 months prior to screening except for stable physiological hormone replacement therapy (i.e., thyroid hormone, estrogen)
History of bariatric surgery
Current liver, renal, pulmonary, cardiac, oncologic, metabolic, gastrointestinal or hematologic disease which the Investigator believes is clinically significant, including:
Self-reported history of hepatitis B, hepatitis C, or HIV
History of recurrent sleep disturbances and/or prone to sleep disturbances based on lifestyle or employment (e.g., variable work schedule, overnight shift work, etc.)
Diagnosis of sleep apnea with or without use of (continuous positive airway pressure)
Major surgery within last 3 months
Blood donation within 4 weeks prior to the screening visit
Participation in another investigational trial within 4 weeks prior to the screening visit. The 4 week window will be derived from the date of the last trial medication and/or blood collection in a previous trial and/or adverse event (AE) related to trial drug to the screening visit of the current trial.
Illicit drug abuse or use of nicotine-containing products within 3 months prior to the screening visit
Poor intravenous access
Blood pressure less than 100/50 mm Hg or greater than or equal to 160/100 mm Hg at screening visit
Heart rate greater than or equal to 100 beats/min at screening visit
Fasting plasma glucose <60 mg/dL or ≥126 mg/dL at screening visit
Translational Research Institute (TRI) staff member or immediate relative of TRI staff member, directly involved with this study
History of any illness or condition that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by study participation
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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